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CoolSculpting Elite Applicator Surface 180 (S180)
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CS-A3-18S-00510(k) K120023
Identity
- Trade Name
- CoolSculpting Elite Applicator Surface 180 (S180) EUDAMED
- Device Name
- CoolSculpting Elite System EUDAMED
- Model / Reference
- CS-A3-18S-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816417023088 EUDAMED
- Basic UDI-DI
- 0816417020001SL EUDAMED
- Direct Marketing DI
- 00816417023088 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
CoolSculpting Elite Applicator Surface 180 (S180) by Zeltiq Aesthetics, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120023 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0816417020001SL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zeltiq Aesthetics, Inc.
- EUDAMED SRN
- US-MF-000004536
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (2)
- EUDAMED c29749c4-74c1-4cb6-9b68-e73171e1d6ef 85 fields · synced Jun 18, 2026
- FDA 510(k) K120023 1 fields · synced May 18, 2026